One-lung VentilationNCT05914285
Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation
A study testing 5ml of inhaled normal saline and 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline in people with One-lung Ventilation and Chronic Obstructive Pulmonary Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- One-lung Ventilation, Chronic Obstructive Pulmonary Disease
- What is being tested?
- 5ml of inhaled normal saline and 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2023to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 40~80yrs, scheduled for videoscope-assisted pulmonary lobectomy
- American Society of Anesthesiologists Class III 또는 IV
- Moderate or more severe COPD according to GOLD criteria (FEV1/FVC<70%, FEV1<80%)
Who cannot join
- New York Heart Association class >II
- AST level ≥100 IU/mL or ALT ≥ level 50 IU/L
- Creatinine clearance < 30mL/min
- History of severe coronary artery occlusive disease, unstable angina, or recent myocardial infarction within 6 months
- History of pulmonary hypertension or pulmonary edema
- History of cerebrovascular accident within 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
About this study
One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Although the protective mechanisms of hypoxic pulmonary vasoconstriction favorably modulate pulmonary perfusion to the ventilated lung, the effect is attenuated in patients with history of chronic obstructive pulmonary disease (COPD), which alters compliance of the pulmonary artery.
Salbutamol is a selective short-acting beta2-agonist and when inhaled during OLV, it acts selectively on the pulmonary vasculature reducing pulmonary vascular resistance of well-ventilated lung. We hypothesized that inhaled salbutamol would alleviate ventilation-perfusion mismatch during OLV of COPD patients, and aimed to assess the effects of salbutamol on oxygenation in these patients.
- Being tested
- 5ml of inhaled normal saline, 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5ml of inhaled normal salineDrug
After the initiation of OLV, 5ml of normal saline is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 30 minutes after the completion of drug inhalation.
2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal salineDrug
After the initiation of OLV, mixture of salbutamol 2.5mg and normal saline 2.5ml is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 30 minutes after the completion of drug inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Normal saline Receives: Drug: 5ml of inhaled normal saline |
| Salbutamol group | Experimental | Salbutamol + normal saline Receives: Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of salbutamol on oxygenation during OLV.
Measured: Thirty minutes after the completion of drug inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start25 Apr 2023
- Primary completion20 Jun 2025
- Study completion21 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for One-lung VentilationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Jun Oh, Principal investigator, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914285
- Sponsor's protocol ID
- 4-2023-0242
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh YJ, Kim N, Choo H, Lee K. Effect of salbutamol during one-lung ventilation in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Can J Anaesth. 2026 Aug 26. doi: 10.1007/s12630-026-03180-w. Online ahead of print.
PubMed 42645752
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT05914285
- Acronym / sponsor ID
- 4-2023-0242
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 21 Jul 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Although the protective mechanisms of hypoxic pulmonary vasoconstriction favorably modulate pulmonary perfusion to the ventilated lung, the effect is attenuated in patients with history of chronic obstructive pulmonary disease (COPD), which alters compliance of the pulmonary artery.
Salbutamol is a selective short-acting beta2-agonist and when inhaled during OLV, it acts selectively on the pulmonary vasculature reducing pulmonary vascular resistance of well-ventilated lung. We hypothesized that inhaled salbutamol would alleviate ventilation-perfusion mismatch during OLV of COPD patients, and aimed to assess the effects of salbutamol on oxygenation in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: 5ml of inhaled normal salineNormal saline |
| Salbutamol group | Experimental | Drug: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal salineSalbutamol + normal saline |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age 40~80yrs, scheduled for videoscope-assisted pulmonary lobectomy
- American Society of Anesthesiologists Class III 또는 IV
- Moderate or more severe COPD according to GOLD criteria (FEV1/FVC<70%, FEV1<80%)
Key exclusion criteria (6 listed)
- New York Heart Association class >II
- AST level ≥100 IU/mL or ALT ≥ level 50 IU/L
- Creatinine clearance < 30mL/min
- History of severe coronary artery occlusive disease, unstable angina, or recent myocardial infarction within 6 months
- History of pulmonary hypertension or pulmonary edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5ml of inhaled normal salineAfter the initiation of OLV, 5ml of normal saline is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 30 minutes after the completion of drug inhalation. | Drug | Control group |
| 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal salineAfter the initiation of OLV, mixture of salbutamol 2.5mg and normal saline 2.5ml is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 30 minutes after the completion of drug inhalation. | Drug | Salbutamol group |
Primary outcome
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
Time frame: Thirty minutes after the completion of drug inhalation
The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of salbutamol on oxygenation during OLV.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Derived from this study: PubMed 42645752Oh YJ, Kim N, Choo H, Lee K. Effect of salbutamol during one-lung ventilation in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Can J Anaesth. 2026 Aug 26. doi: 10.1007/s12630-026-03180-w. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for One-lung Ventilation
RecruitingObservational study
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Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
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Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
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Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Jun Oh principal investigator
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5ml of inhaled normal saline and 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline in people with One-lung Ventilation and Chronic Obstructive Pulmonary Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio) (time frame: Thirty minutes after the completion of drug inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.